NHS watchdog refuses to sanction life-extending cancer drug
A drug that can extend the life of women with advanced breast cancer has been turned down for use in the NHS by the cost-effectiveness watchdog.
The National Institute for Health and Clinical Excellence (NICE) said it plans to block use of Tykerb (lapatinib) in the Health Service after a second review. The decision comes despite rule changes brought in to let people at the end of their lives have the chance of new and often expensive treatments.
It also puts Britain at loggerheads with much of Europe where the drug is given, in combination with a standard chemotherapy drug called capecitabine.
GlaxoSmithKline, Tykerb’s manufacturer, said the latest appraisal would result in 2,000 British women a year being denied access to the treatment. As well as extending life by weeks or months, it has the additional advantage of being taken in pill form.Campaigners have questioned the decision to refuse it. They said the drug met all three conditions: it is used for patients with less than two years’ life expectancy, offers at least three extra months’ life and is licensed for a small number of patients.
Tykerb is the only drug licensed for women with advanced breast cancer for whom Herceptin is no longer working. However NICE said that at £1,600 a month for each patient, plus the added cost of capecitabine, the treatment did not represent a cost-effective use of resources.
Its complicated quality assessment valued the drug at £59,000 per life year — higher than the £30,000 threshold it normally applies, although no specific limit has been stipulated since the rules for end-of-life drugs changed.Nice concluded that the drug “is not recommended for the routine treatment" of women with advanced breast cancer once Herceptin has failed, although they can be given it in clinical trials. The appraisal is now open to consultation.
The treatment came to public attention after Jane Tomlinson, the charity fundraiser, became one of hundreds of British women to benefit from the programme. She died in 2007 at the age of 43.
Mike Tomlinson, her widower, condemned the ban when it was first proposed earlier this year, saying Nice had failed the “acid test” on being more flexible with life-extending drugs to terminally ill patients.
One of Nice’s reservations concerns the amount of extra life that Tyverb offers women. The evidence from trials suggested they lived for an extra 2.4 months on average. Under the new end-of-life rules, a drug should normally give an extra three months survival.
Gillian Leng, Nice’s deputy chief executive, said: “The appraisal committee considered the updated economic evaluation presented by the manufacturer but was not persuaded that the adjusted estimates of overall survival presented were robust.
“The committee therefore concluded lapatinib is not a cost-effective use of NHS resources.”
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